Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment, filed on 12-Aug-2026, is acknowledged.
Claims 20 are newly amended.
Objections Withdrawn
Claim 20 was previously objected to because of the term “MAMs” without definition or prior introduction. Claim 20 has been amended to address this issue, and objection is withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gan et al. (WO2015138237, Published 17-Sep-2015), and further in view of Kohakuyuki (24-Oct-2021), Silab (Pro-Coll-One+, 05-Sep-2021), Alpaflor (Nectapure PF Datasheet, 10-Nov-2016), and Neogen DermaTV (23-Jun-2018).
For Claims 1-3, 7, and 14, Gan teaches the composition of Table 10 comprising of 2 wt% niacinamide, 0.01 wt% edelweiss extract, and 0.2 wt% panthenol (Page 40).
For Claim 4-6, 9-11, 13, 15-16, 18-20, Gan teaches the composition of Table 10 comprising of water at 73 wt%, butylene glycol at 5 wt%, does not contain retinoids (Page 40), administered topically (Page 34, paragraph 99), a face mask (Page 34, paragraph 99), treating sensitive skin (Page 19, Paragraph 30), reducing symptoms of sensitive skin (Page 19, paragraph 30), and exposure to irritants (Page 13, paragraph 41).
For Claims 8, 17, Gan teaches titanium dioxide and zinc oxide can be added to the composition as a physical sun block (Page 20, paragraph 61).
Gan does not teach 0.001%-10% rice (Oryza sativa) lees concentrate, 0.001%-2% rice (Oryza sativa) lees concentrate, 0.001%-5% soy-derived glycopeptides, 0.002%-4% soy-derived glycopeptides, 0.01%-2% adenosine, 0.0001%-3% Buddleja davidii extract, or 0.0001%-3% Thymus vulgaris extract in the composition of Table 10 of Claims 1-3, 7, and 14. Gan does not explicitly teach a light protective filter comprising of zinc oxide, titanium dioxide, iron oxide, and wrinkle reduction or delay in the composition of Table 10 of Claim 8 and 12. For this reason Kohakuyuki, Silab, Alpaflor, and Neogen DermaTV is added.
Kohakuyuki teaches that the rice extract contributes to a moisturizing effect, and noticeably reduces dry areas on the skin (Page 6). Silab teaches that soy-derived glycopeptides contribute towards a marked reduction in wrinkles (Page 3). Alpaflor teaches Buddleja davidii extract and Thymus vulgaris extracts that contain rich amounts of active compounds like iridoids, flavonoids, thymol, and rosemarinic acid (Page 1) useful for protecting skin against oxidative damage. Neogen DermaTV teaches that adenosine at 0.04 wt% strengthens skin cells in the dermis layer and is effective in improving wrinkles (Pages 5-7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cosmetic composition of Gan to incorporate the additional cosmetic additives taught by Kohakuyuki, Silab, Alpaflor, and Neogen DermaTV because each reference teaches ingredients conventionally used in topical cosmetic compositions for improving skin moisturization, reducing irritation, protection against environmental stressors, and improving wrinkle appearance on sensitive skin. One would have been motivated to combine these known cosmetic ingredients with the composition of Gan to achieve the predictable result of enhancing the overall skin care benefits of the composition, particularly for sensitive skin.
Furthermore, cosmetic formulations are optimized through the routine addition of known skin benefit active agents to improve characteristics such as moisturizing, soothing, anti-wrinkle properties. The selection of known cosmetic additives for their known functions represents the predictable use of prior art elements according to their established functions.
Additionally, the claimed concentration ranges would have been obvious as a matter of routine optimization of result-effective variables because the cited references teach the same ingredients for the same intended cosmetic purposes, and adjusting the ingredient concentrations would have been routine experimentation. For the foregoing reasons, Claims 1-20 are rendered obvious by the teachings of the prior art.
Response to Arguments
The Applicant’s arguments, filed on 12-Aug-2026, have been fully considered but are not persuasive.
Section A: Applicant’s argument that the recited reference Kohakuyuki (2021) (hereinafter Kohakuyuki) fails to teach or suggest “at least ‘0.001% - 10% rice (Oryza sativa) lees concentrate,’ as recited in claim 1” is not persuasive.
Applicant argues that Kohakuyuki does not teach the claimed 0.001%-10% rice (Oryza sativa) lees concentration because Kohakuyuki discloses a “Sake Lees Aging Fermented Extract” which Applicant characterizes as a composition different from rice lees. Applicant’s argument is not persuasive.
Kohakuyuki expressly identifies the disclosed cosmetic ingredient as “ORYZA SATIVA (RICE) LEES EXTRACT” (Page 8). Kohakuyuki further explains that “[s]ake is manufactured by fermenting rice, koji, yeast, and clean water. Sake lees are a by-product obtained after filtering sake during the manufacturing process” (Page 2). Furthermore, Kohakuyuki discloses “Sake lees are carefully fermented at low temperature for more than 1,000 hours through a two-stage process, resulting in aged sake lees with a soft texture. The extract from fresh sake lees is clear and colorless, while that from aging sake lees has a beautiful amber color. This shows that the fermentation-derived ingredients have been concentrated and enriched through aging. KOHAKUYUKI ‒Sakes Lees Aging Fermented Extract was developed by refining this extract to the specification that make it easy to formulate into cosmetics” (Page 3). Thus, the terminology “Sake Lees Aging Fermented Extract” is expressly taught by Kohakuyuki as an extract of Oryza sativa (rice) lees for use as a cosmetic ingredient. Applicant’s distinction between “sake lees” and “rice lees” is therefore not persuasive. The instant claim does not exclude rice lees that have been subject to fermentation or aging, nor does the claim require a specific or particular process for producing the rice lees concentrate.
Moreover, the instant specification describes the claimed rice (Oryza sativa) lees concentrate as comprising Oryza sativa lees extract. The fact that Kohakuyuki identifies the cosmetic ingredient as an aged or fermented sake lees extract does not establish that the material is outside the scope of the instant claimed rice (Oryza sativa) lees concentrate.
Furthermore, Kohakuyuki teaches a recommended formulation concentration of 1-3% for the disclosed rice lees extract, which falls within the claimed range of 0.001-10%. Kohakuyuki also evaluates formulations containing differing concentrations of the extract at 0.2, 0.8 and 4 wt%, reporting a correlation between concentration dependent antioxidative effects.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, Applicant’s argument that the cited combination fails to teach or suggest the claimed rice (Oryza sativa) lees concentrate is not persuasive, and the rejection of claims 1-20 under 35 U.S.C. § 103 is maintained.
Section B: Applicant purport unexpected results does not overcome prima facie obviousness.
Applicants argue that the claimed compositions resulted in unexpected and synergistic properties based on the in vitro and in vivo testing reported in Example 1. The argument has been considered and found not persuasive.
Applicant characterizes the results of Example 1 as being a synergistic effect, however, that is overstated: “[a]n important sign of healthy skin aging is the presence of pro-collagen and elastin, whose expression of moth mRNA and protein was highly induced by the composition comprising the active ingredients, whereas no effect was observed by each active ingredient along” (Paragraph 299). The instant specifications demonstrate that the tested combination exhibited an effect not observed with individual active ingredients but does not quantitatively establish that the combination produced a synergistic effect exceeding the expected additive effects of the individual components, and therefore no synergy can be established.
Furthermore, the applicant argues that the instant composition was compared to a retinol serum, including in the +582% IL-8 and -69% PGE2 expression. However, this comparison does not establish unexpected results over the closest prior art. The primary art, Gan et al. (WO2015138237, Published 17-Sep-2015) (hereinafter Gan), does not recite retinol as the composition to be modified. Rather, Gan teaches a topical composition for sensitive skin, and the secondary art teaches additional cosmetic active ingredients and their known skin care functions. Recitation of the instant composition of Example 1 producing a different inflammatory response than a retinol containing serum does not establish that the properties of the claimed invention would have been unexpected from the combination of Gan and secondary art.
Furthermore, the general properties identified by the Applicant are expressly taught by the cited prior art. Kohakuyuki teaches that Oryza sativa (rice) lees extract provides skin moisturizing effect, and skin-barrier benefits, and is useful for sensitive skin, increases skin elasticity, and antiaging effects (Page 4). Kohakuyuki further discloses concentration dependent antioxidant activity associated with the extract at 0.2%, 0.8%, and 4% concentration (Page 5), with recommended formulation ratios of 1-3% (Page 8). Thus, the observation that a composition containing rice lees exhibits antioxidant, moisturizing, barrier, collagen, elasticity, or antiaging effects does not establish that such properties would have been unexpected in view of the prior art.
Applicant’s argument regarding pollution induced mitochondrial dysfunction is found not persuasive. Applicant asserts that the mitochondrial effects are “per se unexpected” because pollution induced mitochondrial dysfunction was not expressly mentioned in the cited references. The absence of an express disclosure of a particular mechanism does not establish that an unobserved property was unexpected. The prior art already teaches the antioxidant and protective properties of the rice lees ingredient, including data regarding concentration dependent antioxidant activity. Applicants have not established the particular mitochondrial effects reported in the instant specification to represent an unexpected result in performance attributable to the claimed combination versus known antioxidant activity related known endpoints.
Finally, the unexpected results argued by the applicant are narrower in scope than the claims. Table 1 (Paragraph 304) is copied below, noting that example 1 was a clinical evaluation with Compositions 3 and 4:
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The claims encompass compositions having the claimed active ingredients and much broader concentration range (0.1%-10% Panthenol, 0.0001%-10% Edelweiss extract, 0.001%-10% Rice Lees concentrate, 0.002%-4% Soy-based glycopeptides form claim 3, and 0.1-10% niacinamide) as well as additional embodiments recited in the dependent claims. The unexpected results are not commensurate in scope with the instant claims.
Accordingly, the Applicant’s experimental evidence has been considered, and the evidence does not establish a demonstrable synergistic effect, nor does it establish unexpected results over the closest prior art. For the foregoing reason, the Applicant’s arguments have been fully considered, and found not persuasive, and the rejection of claims 1-20 under 35 U.S.C. § 103 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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/W.L./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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